Nice Sore Throat Spearmint

Nice Sore Throat Spearmint
SPL v4
SPL
SPL Set ID 5fc68f04-ec15-11c0-e053-2a91aa0a1952
Route
ORAL
Published
Effective Date 2014-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenol (1.4 g)
Inactive Ingredients
Propylene Glycol Glycerin D&c Green No. 5 Water Saccharin Fd&c Green No. 3 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-03-07

Description

Active Ingredients Purposes Phenol 1.4% Oral Anesthetic/ Analgesic


Medication Information

Description

Active Ingredients Purposes Phenol 1.4% Oral Anesthetic/ Analgesic

Uses

For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Section 55105-1
Active Ingredients Purposes
Phenol 1.4% Oral Anesthetic/ Analgesic

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Directions
  • apply to the affected area
  • allow to remain in place for at least 15 seconds, then spit out
  • use every 2 hours or as directed by a doctor or dentist
age dose
adults and children 12 years of age and older for each application, spray 5 times
children 3 to under 12 years

should be supervised in use of this product

for each application, spray 3 times

children under 3 years of age consult a doctor or dentist

Questions?

1-855-452-9500 or email at [email protected]

Distributed By:

LEOSONS

Albany, New York 12205

Made in USA

Other Information
  • store at room temperature

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

Inactive Ingredients

D&C green #5, D&C yellow #10, FD&C green #3, flavor, glycerin, propylene glycol, sodium saccharin, and water.

Principal Display Panel

SUGAR FREE • ALCOHOL FREE • ASPIRIN FREE

N'ICE®

P H E N O L / O R A L A N E S T H E T I C

Sore Throat Spray

Fast acting, long lasting relief of minor sore throat and mouth pain

SPEARMINT FLAVOR

6 FL OZ (177 mL)

When Using This Product
  • do not use more than directed.
Stop Use and Ask A Doctor If
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops
  • difficulty in breathing occurs
If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep This and All Drugs Out of Reach of Children.

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.


Structured Label Content

Uses

For temporary relief of occasional minor irritation, pain, sore mouth, sore throat and pain associated with canker sores.

Section 55105-1 (55105-1)
Active Ingredients Purposes
Phenol 1.4% Oral Anesthetic/ Analgesic

Warnings

Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.

Directions
  • apply to the affected area
  • allow to remain in place for at least 15 seconds, then spit out
  • use every 2 hours or as directed by a doctor or dentist
age dose
adults and children 12 years of age and older for each application, spray 5 times
children 3 to under 12 years

should be supervised in use of this product

for each application, spray 3 times

children under 3 years of age consult a doctor or dentist

Questions?

1-855-452-9500 or email at [email protected]

Distributed By: (Distributed by:)

LEOSONS

Albany, New York 12205

Made in USA

Other Information
  • store at room temperature

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS TORN, BROKEN OR MISSING.

Inactive Ingredients

D&C green #5, D&C yellow #10, FD&C green #3, flavor, glycerin, propylene glycol, sodium saccharin, and water.

Principal Display Panel

SUGAR FREE • ALCOHOL FREE • ASPIRIN FREE

N'ICE®

P H E N O L / O R A L A N E S T H E T I C

Sore Throat Spray

Fast acting, long lasting relief of minor sore throat and mouth pain

SPEARMINT FLAVOR

6 FL OZ (177 mL)

When Using This Product (When using this product)
  • do not use more than directed.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • sore mouth symptoms do not improve in 7 days
  • irritation, pain or redness persists or worsens
  • swelling, rash or fever develops
  • difficulty in breathing occurs
If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professional before use.

Keep This and All Drugs Out of Reach of Children. (Keep this and all drugs out of reach of children.)

In case of accidental overdose, seek professional assistance or contact a Poison Control Center right away.


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Raw Label Data

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